On August 4, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported second quarter 2021 financial results and highlighted recent achievements and developments (Press release, Oncorus, AUG 4, 2021, View Source [SID1234585725]).

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"We’re pleased that our Phase 1 clinical trial of ONCR-177, our lead oHSV candidate, continues to enroll and progress as expected, and we remain on track to report initial clinical data in the fourth quarter of this year. ONCR-177 is unique among oHSVs in that it retains the ability to resist interferon via retention of γ34.5 and is armed with five complementary immunomodulatory payloads in order to drive systemic activity," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer at Oncorus. "This quarter, we also announced the nomination of our lead Synthetic vRNA immunotherapy candidates, ONCR-021 and ONCR-788, which we plan to investigate in multiple cancers, including those of the lung. Our proprietary Synthetic vRNA Immunotherapy Platform involves a novel combination of RNA- and viral immunotherapy-based modalities. To date, we believe that neither of these modalities has reached its full potential due to several well-established challenges, which we believe we can overcome through our novel and innovative approach and, in doing so, potentially create a new pillar of therapy for cancer patients."

Second Quarter 2021 and Recent Highlights

Continued to progress Phase 1 clinical trial of ONCR-177. Oncorus continues to enroll patients in a Phase 1 clinical trial of its lead oHSV product candidate, ONCR-177, an intratumorally (iTu) administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The Phase 1 open-label, multi-center, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177 alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. Oncorus anticipates reporting initial interim data from the Phase 1 trial in the fourth quarter of 2021.
Announced nomination of its first Synthetic vRNA immunotherapy clinical candidates, ONCR-021 and ONCR-788. In May 2021, Oncorus nominated its first Synthetic vRNA immunotherapy clinical candidates, ONCR-021 and ONCR-788. Oncorus’ pioneering IV-administered approach involves encapsulating the genomes of RNA viruses known to kill cancer cells (i.e., oncolytic viruses, or OVs) in a lipid nanoparticle (LNP), creating a Synthetic vRNA immunotherapy. ONCR-021 encodes an optimized strain of Coxsackievirus A21 (CVA21), and ONCR-788 encodes a modified version of the Seneca Valley Virus (SVV). Both CVA21 and SVV have extensive clinical experience and favorable safety profiles when administered IV. Oncorus’ novel Synthetic vRNA approach holds the potential for IV-administration and avoids the challenge of neutralizing antibodies seen in previous approaches with IV-administered OVs. Oncorus plans to investigate its novel Synthetic vRNA immunotherapies in multiple histologies, including cancers of the lung, both as monotherapy and in combination with immune checkpoint inhibitors and other cancer treatments.

Click here to read a white paper published by Oncorus’ leadership on its Synthetic vRNA Immunotherapy Platform and lead candidates and here for the slide deck presented at Oncorus’ recent investor meeting. Click here to view an animation depicting Oncorus’ novel Synthetic vRNA immunotherapy approach.
Continued to advance second oHSV viral immunotherapy candidate, ONCR-GBM, toward candidate nomination. Leveraging its oHSV Platform, Oncorus is pursuing ONCR-GBM to specifically target brain cancer, including glioblastoma multiforme (GBM). The company is utilizing its knowledge of microRNA expression to engineer a microRNA attenuation strategy to protect healthy brain tissue and to select a combination of payloads intended to address the specific drivers of immune suppression in brain cancer.
Progressed buildout of Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility. Oncorus continues to make progress building out its state-of-the-art, 88,000 square foot GMP viral immunotherapy clinical manufacturing facility in Andover, Massachusetts. The facility, for which Oncorus has signed a 15-year lease, is intended to provide a comprehensive solution for Oncorus’ Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality control and supply of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling and clinical studies. The company remains on track to complete the first phase of the facility’s buildout in 2021, including process development and quality control, with GMP multi-product manufacturing capabilities and full operation expected to commence in the first half of 2023.
Expanded Board of Directors with two new appointments. Oncorus expanded its Board with the appointments of Eric H. Rubin, M.D., and Barbara Yanni, in June 2021 and July 2021, respectively. Dr. Rubin currently serves as Senior Vice President of Global Clinical Oncology at Merck, known as MSD outside of the United States and Canada. Ms. Yanni was formerly Vice President and Chief Licensing Officer at Merck, prior to her retirement in 2014.
Second Quarter Financial Results

Cash and cash equivalents were $159.9 million as of June 30, 2021 compared to $130.3 million as of December 31, 2020.
Research and development expenses for the quarter ended June 30, 2021 were $10.7 million compared to $6.7 million for the corresponding quarter in 2020. The increase in research and development expenses was mainly attributable to increased personnel-related expenses, including stock-based compensation, which was driven by increased headcount, increased rent expense related to the Company’s new manufacturing facility and increased development costs related to the Company’s nominated candidates.
General and administrative expenses for the quarter ended June 30, 2021 were $4.9 million compared to $2.0 million for the corresponding quarter in 2020. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses, including stock-based compensation, which was driven by increased compensation and increased headcount and other increased costs, such as insurance expense and professional and consultant expenses, related to operating as a public company.
Net loss attributable to common stockholders for the quarter ended June 30, 2021 was $15.5 million, or $0.60 per share, compared to a net loss attributable to common stockholders of $12.1 million, or $12.09 per share for the same quarter in 2020. The share and net loss per share amounts in the second quarter of 2021 reflect the impact of the company’s IPO, which closed in October 2020, including the conversion of outstanding preferred stock into approximately 15.0 million shares of common stock.
Financial Guidance

Based upon its current operating plans and cash and cash equivalents, Oncorus expects to have sufficient capital to fund its operating expenses and capital expenditure requirements into late 2023.